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Evaluation of risk factors for the development of diabetic retinopathy (DR) in patients with type 2 diabetes: comprehensive analysis with optical coherence tomography (OCT), VEGF and biomarkers of inflammation

Evaluation of risk factors for the development of diabetic retinopathy (DR) in patients with type 2 diabetes: comprehensive analysis with optical coherence tomography (OCT), VEGF and biomarkers of inflammation - OCT-VEGF II

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00027805
Enrollment
100
Registered
2022-01-18
Start date
2020-10-06
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA 10012689 MedDRA 10012688

Interventions

Group 1: Patients are obliged to attend the study site for 1 visit.

Sponsors

GWT TUD GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Written informed consent • Patients with type 2 diabetes mellitus (T2DM) for whom datasets from the previous studies are available • Ability to understand and follow study-related instructions

Exclusion criteria

Exclusion criteria: • Acute infection within 14 days prior to screening • Acute inflammatory disease within 14 days prior to screening or current chronic inflammatory disease • Pre-existing autoimmune disease • Treatment with immune suppressive drugs within 14 days prior to screening • Systemic treatment with glucocorticoids within 14 days prior to screening • Myocardial infarction or stroke within 1 year before inclusion • Surgeries (including intravitreal injections) within the previous 3 months • Oncological disease within the previous 5 years • Women who are pregnant or breast-feeding

Design outcomes

Primary

MeasureTime frame
The primary objective of this observational study is to determine the prognostic value of traditional and new risk factors for development of DR and progression of DME, respectively.

Secondary

MeasureTime frame
Secondary objectives of the study are to • investigate the impact of quality of diabetes and risk factor control on development of FRT • identify high-risk groups for FRT and DR • develop a guide for OCT diagnostics in managed care programs

Countries

Germany

Contacts

Public ContactKatrin Engelmann

Augenklinik der Klinikum Chemnitz gGmbH

augenklinik@skc.de+49 371 33333230

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026